Pharma

Pharmaceutical companies must comply with many laws, standards, and rules of different source and type.

Skytechnology supports Customers to use computerized systems in a compliant way, thanks to the expertise in product/process compliance and in product development.

Skytechnology offers a whole set of services:

• Validation of computerized systems including
  • Acquisition of Customer’s SOPs from the QA Officer regarding computer validation, change control, security and eventually the Validation Master Plan
  • Acquisition of department and system relevant SOPs from System Owner
  • Preparation of Validation Plan
  • Definition of a Risk Assessment
  • Identify of user requirements to define the intended use
  • Life cycle control in case of developed systems and performance of Design Qualification
  • Preparation of SOPs relevant to use, management, security and change control relevant to the system under validation
  • Training to users about SOPs
  • Definition of Qualification Protocols with relevant traceability matrices
  • Test execution and issue of the relevant Qualification Reports
  • Management of non-conformances in accordance to Customer’s SOP.

 

• Periodic review of validated computerized sytems to ensure that computerized systems are still validated in accordance with Customer’s SOP or a with ad hoc SOP written by Skytechnology

 

• Quality management services:
  • Quality system maintenance with preparation and update of SOPs and instructions
  • Support to incoming audits and audits to supplier
  • Support to the management of CAPA
  • Management of complaints according to 21 CFR requirements

 

• Training made according to customer needs. Training subjects include: 21 CFR Part 11, Annex 11, Computer Validation.